Meeting highlights from the PRAC meeting in April 2017


At its meeting held at the in April 2017, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) continued the review within Article-31 referral procedures for:

  • modified- and prolonged-release paracetamol medicines
  • injectable medicines for treatment of allergic reactions that contain lactose from cows' milk
  • factor VIII medicines
  • retinoid medicines
  • systemic and inhaled quinolone and fluoroquinolone antibiotics.

The PRAC did not initiate or conclude a referral at this meeting. At this meeting, PRAC completed the safety review of Uptravi (selexipag), in the context of a safety signal. This medicine has not been placed on the Croatian market.

Following to the Article-31 referral procedure for gadolinium-containing contrast agents, for which PRAC had adopted recommendations at its March 2017 meeting, some of the marketing authorisation holders concerned by this referral procedure have requested a re-examination. Upon receipt of the grounds for their requests, the PRAC will start a re-examination, which is expected to conclude in July 2017.

More information on the April 2017 PRAC meeting can be found here.